The U.S FDA’s response to the pandemic has been all-consuming, but epidemiologist Michael Mina of Harvard blasted the agency’s handling of rapid testing. Mina said the agency is in possession of emergency use authorization (EUA) filings for rapid antigen tests that should be acceptable, but that the FDA is “the only bottleneck” in the rapid antigen testing pipeline.

Mina was recently involved in a debate over the role of antigen testing in connection with a pilot testing program in the U.K., during which he and several others pushed back against claims that the pilot was coming up short of the promised effect. Mina’s Feb. 24 briefing was held in conjunction with the release of a survey of Americans that strongly suggested great interest in surveillance testing, although costs and privacy matters are seen as two impediments.

Applications for antigen tests ‘are stellar’

Mina, an assistant professor of epidemiology at Harvard’s Chan School of Public Health, said that while cases are going down of late, any plausible state of normalcy might not return until autumn 2021 at the earliest. Testing will help accelerate a return to normalcy, but another surge of cases might be reasonably expected before the end of the year. Mina said he has personally seen at least one emergency use authorization filing for rapid antigen tests, adding, “these applications are stellar. There is absolutely no reason for an inexpensive $3 or $4 test to be outright rejected or sitting in queue for many months.”

At least one such applications has been in queue at the FDA since last fall, but “had they been available, we could have potentially prevented huge numbers of outbreaks and hundreds of thousands of deaths,” Mina stated and thus, the FDA “is at the center of preventing Americans from getting tools that will help limit the spread” of the SARS-CoV-2 virus.

There is one company that has a test it can produce at a volume of millions per day, but this company, which Mina declined to identify, is shipping most of its production to the U.K. He said he is aware of the results of this test’s validation data and that the results “are excellent,” suggesting that the test performs as well as the Binax Now test by Abbott Laboratories, of Abbott Park, Ill. The test in question may be the lateral flow test by Innova Medical Group Inc., of Pasadena, Calif., which is the test used in the Liverpool, U.K., pilot program.

At least one company located in the U.S. could produce millions of lateral flow antigen tests per day, but Mina said, “this test was outright rejected by the FDA,” who is said to have relayed to the sponsor that this was not a priority test type. The test in question serves the type of public surveillance test the agency has said it wants to prioritize, and Mina said the FDA’s explanation for not granting the sponsor an EUA “just doesn’t smell right.”

Mina said he is nearly certain the FDA has an application from Thermo Fisher Scientific Inc. for a rapid antigen test, and assuming the application is in at the FDA, “to not bring that to the top of the pile … would be crazy.” There are tests available for about $25 each, but that test might only cost $5 to the end user if no physician order was required. A physician can make a substantial amount of money just writing prescriptions for tests, something Mina said “is not the practice of public health. It is in the process of eroding” medical practice. The net effect of the picture, he said, is to make clear that the FDA is “the only bottleneck in all of this.”

Popular adoption of at-home testing is price sensitive

Mina said one of the major questions for the foreseeable future is whether the public will adopt rapid testing for in-home use, and made reference to a survey sponsored by the COVID Collaborative that returned some interesting results. While the responses regarding home use were encouraging, fewer than two in five respondents had ever heard of rapid antigen tests.

Shawna Marino, a policy advisor at the Chan School, noted that Congress is looking at a $46 billion investment in testing per recent budget legislation, but noted that the Biden administration has yet to publish a national testing strategy. The survey indicated that Americans see testing as on par with masking and vaccines as a response to the pandemic, but roughly 64% of those in the U.S. have never been tested.

A large share of the respondents indicated that access is an issue, despite that 86% of respondents are eager to use rapid home tests. However, only 36% have heard of a rapid antigen test, which Marino said makes clear that “this is still a fringe issue” in the popular consciousness. Despite the sizeable popular support for at-home testing, that support is sensitive to price. At $25 or more, the price of the only EUA-authorized at home tests would be routinely used by only 33% of respondents, but that share jumps as the price falls.

Marino and Mina are calling on Congress to set aside at least $20 billion of the $46 billion toward a national rapid testing program, but one of the hurdles has been reporting of test results. Most Americans claim they will report their results, but Marino noted that privacy is still a consideration.